This invention relates to an article of manufacture, namely, a calf, ankle and foot orthotic support device for men, women and children that allows the heel to float or be suspended, provides compression to the leg, and provides support for the foot. These articles are lower extremity management systems, and are sometimes called ankle/foot orthotics (AFO). As used herein, the terms xe2x80x9corthotic devicexe2x80x9d and xe2x80x9corthotic support devicexe2x80x9d mean an apparatus used to support, align, prevent, or correct deformities. This device includes a rigid, U-shaped or O-shaped support member, or a flexible support member that, in use, assumes an O-shape or a U-shape. These support members have a plurality of bags mounted inside the support member. These bags are at least partially filled with cushioning material such as particulates or natural fiber.
In a first embodiment, this device comprises a rigid, preferably thin-walled, U-shaped shell. Within this shell is a U-shaped block of sufficient thickness, rigidity, and flexibility to support the ankle, foot and heel of a user. Preferably, the U-shaped block is attached to the inner surface of the shell.
The shell is preferably made of a plastic such as a polycarbonate, ABS, or another plastic material. The shell is preferably about five to about twenty inches in length, about ten to about twenty-five inches in width, and about one-sixteenth of an inch to about five-sixteenths of an inch in thickness. In preferred embodiments, the shell is about three to about six inches longer than the U-shaped block at one end of the block.
The U-shaped block is preferably made of a foamed plastic such as cross-linked polyethylene, and may have a thickness ranging from about two to about four inches, at its thickest dimension, to about one-half inch to about two inches at its thinnest dimension. The inner profile of the block is U-shaped. Its outer profile is also U-shaped, terminating at the upper edges of the block in inwardly tapering or straight surfaces. The degree of taper from the legs of the U-shaped block is in the range of about twenty-five percent to about seventy-five percent.
Within this U-shaped block, and attached to its inner surface, are one or more scaled bags, preferably sealed fabric bags, at least partially filled with cushioning material. Preferably, these bags extend over substantially the entire length of the U-shaped block. The bags are wide enough to form a U-shaped or O-shaped supporting surface for the calf and ankle. The bags are preferably made of a material such as Spandex or another sturdy elasticized fabric.
A second embodiment includes a U-shaped outer member preferably made of a foamed plastic, or a plurality of foamed plastic layers joined to one another. This outer U-shaped support member can vary in thickness from about one inch or more at one end to about 0.5 inch at the other end, and is preferably thicker at the bottom of the U-shaped member than at the top of the side walls forming the U-shape.
Within this outer foamed U-shaped member is a thinner, more rigid plastic sheeting layer, preferably having a uniform thickness from end-to-end, and from the bottom of the U-shape to the top. Preferably, this thickness is in the range of about one-sixteenth of an inch to about thirteen-sixteenths of an inch.
Atop this rigid plastic sheeting is another foamed member whose dimensions are similar to those of the outer foamed member(s). Like the outer foamed members, this member can include a plurality of pieces of foam laminated or otherwise joined together.
Attached to the inner surface of the first and the second embodiments are one or more sealed bags at least partly filled with a cushioning material such as particulate solids, feathers or fibers such as wool. Preferably, the sealed bags are generally tubular, are approximately the same length as the support member, and have a cross-sectional area in the range of about four to about twenty-five square inches. Where a plurality of bags are used, one or more bags may be attached to one another, and/or one or more may be unattached to others.
In some embodiments, there are at least three such bags, with one such bag at the bottom of the U-shaped member, and another along each inner side of the U-shaped member. Another bag, whether unattached to the others or attached to one of the side bags, is positioned to extend over the top of a user""s calf when the user""s calf is placed into the U-shaped member. In other embodiments, there may be five, six or more bags, with two or more bags attached to one another, and others unattached to any other bag.
Preferably, the cushioning materials are loose inside the bags, and comprise particulates such as styrofoam or other plastic beads, seeds or natural materials such as feathers or fibers. Where the cushioning material is styrofoam beads or seeds, these particulates preferably have a diameter of less than about one-eighth of an inch, preferably less than about three thirty-seconds of an inch. Their volume is smaller than the inner volume of the sealed bag to permit both movement of the cushioning material, and support for an ankle, foot, calf and/or heel resting on the outer surface of the bags, without substantial abrasion. Preferably, the volume is also sufficient to avoid ulceration, and/or ischemia in the ankle, foot or heel of a user. The cushioning material preferably occupies at least about thirty percent and up to about ninety-five percent of the inner volume of each sealed bag.
In other embodiments, the U-shaped support member is flexible and/or bendable. In such embodiments, the U-shaped member may include a plurality of tubular air bags joined edge-to-edge to form a structure similar to an air mattress. Attached to one surface of the air mattress are one or more support bags filled at least in part with the cushioning material. The bags may, but need not all be the same length. Some of the bags may be longer than others to provide better support to the ankle and foot. Other bags for use atop the calf of a user may be shorter.
In all embodiments, the devices include one or more straps, e.g. Velcro straps or webbing, to hold the support device to the foot and ankle of a user. In some embodiments, these straps pass over one or more sealed bags containing cushioning material placed atop a user""s calf/lower leg resting within the support device, such that the straps hold the topmost bag firmly against the top of the user""s calf/lower leg.
The straps may be attached to an inner or the outer surface of the device to removably or detachably secure the orthotic device to the lower leg of a user. With these straps, the device can be bound firmly to the calf of a user to provide compression.
In preferred embodiments, the support device also includes a foot pad that engages and supports the sole of a user""s foot. Since a user""s foot extends beyond the end of the support device, the foot is susceptible to foot drop, foot contracture, or both. The foot pad minimizes these undesirable results.
The foot pad itself is a foot-sized bag at least partially filled with cushioning material such as particulate solids, feathers or fibers such as wool. Preferably, at least about thirty-five percent of the volume of the bag is filled with such cushioning material. More preferably, at least about fifty percent of the volume of the bag is filled with such cushioning material. The foot pad also includes a stiffener on the side of the bag opposite the side that contacts the foot of a user. The stiffener can be made of firm duck, thermoplastics such as polyethylene, ABS, polypropylene or polycarbonate, or other rigid materials, and may be molded in a desired shape, e.g. the shape of the bottom of a user""s foot. The foot pad may have a sleeve or pocket to permit insertion and removal of one or more stiffeners of differing sizes and shapes. The pocket or sleeve preferably includes, at its opening, a closure e.g. a Velcro closure to hold the stiffener in place in the sleeve or pocket. For example, an insertable stiffener may be shaped to conform to the base of a user""s foot, and/or the stiffener may function like the sole of a shoe, thus permitting a user to be ambulatory.
The foot pad is attached to, and preferably separable from a supporting strap by fasteners such as Velcro and can be positioned along the strap to maximize a user""s comfort.